Korean drugmaker seeks approval for COVID-19 antibody treatment after trial shows it is 'well-tolerated'
Regulatory approval given for Phase 3 clinical trial for antibody drug CT-P59
South Korean biopharmaceutical firm Celltrion said its COVID-19 antibody drug, CT-P59, was well-tolerated without significant safety issues in the study population of its ongoing Phase 1 clinical trial.
"Trial results indicate treatment with CT-P59 resulted in at least 44% faster recovery time when compared with placebo," the company said in a statement. Celltrion added that no patients treated with CT-P59 in the study have so far required hospitalization or other antiviral therapy as a result of COVID-19.
Last month, the South Korean drugmaker said it received regulatory approval for Phase 3 clinical trials of the experimental COVID-19 treatment.
The company plans to seek conditional approval for CT-P59 for emergency use by the end of this year. The treatment, the most advanced antibody drug in terms of research in South Korea, is directed against the surface of the coronavirus and designed to block it from locking on to human cells.
Celltrion began commercial production of the drug in September, which is likely to amount to around 1 million doses, in anticipation of demand in both domestic and overseas markets.